Guidelines for records control and documents retention

The quality management system is based on records to maintain, according to the requirements of ISO 15189 standard and those of the French regulation as well, to ensure traceability of data. This article provides the nature of information and documents to be stored by the laboratory and the time they have to be maintained according to the French regulation. Moreover, it provides recommendations for the management and the control of records. Auditing the traceability of activities being a part of the elements of verification by COFRAC evaluators, a frame form for audit is also provided for self-assessment and preparation of accreditation.